Veteran Peer-Assisted Computerized Cognitive Behavioral Therapy for Depression

NCT02057042 | Completed Results DMC

• 1 other identifier: IIR 13-310
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 3

Brief Summary

The investigators will conduct a randomized clinical trial of Peer-Supported cCBT versus enhanced usual care (EUC) for 330 patients with new episodes of depression in primary care at three VA sites and their associated Community-Based Outpatient Clinics (CBOCs).

Conditions

Depression

Keywords

Peer Support; cCBT; primary care

Outcome Measures

Primary Outcomes (4)

• Functional Status

  Functional status will be measured using the Veterans RAND 12-Item Health Survey (VR-12). Developed from VR-36, VR-12 includes 12 original question items from the VR-36. The questions in this survey correspond to seven different health domains inlcuding general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy/fatigue levels, social functioning and mental health. Answers are summarized into a Physical Component Score (PCS) and a Mental Component Score (MCS) which allows for a comparison between the respondents physical and psychological health status.The VR-12 has somewhat greater precision at the lower end of the health status continuum than the SF-12. The VR-12 has been used in numerous prior VA focused studies. VR-12 MCS component scores are standardized to a mean of 50, with higher scores indicating better mental health and related functioning.

  change over time (baseline, 3 months, 6 months)

• Depression Symptoms

  Inventory of Depressive Symptoms (IDS) at baseline, 3 months post intervention and 6 months post intervention. The ISD is a 16-item self-report instrument for measuring the severity of depression among individuals. Each item is rated on a four-point scale (0-3), and aggregate scores range from 0 to 27. The IDS has been widely used and shows acceptable reliability, with Cronbach's of 0.86. Severity of depression is scored according to the following ranges: 1-5 (no depression), 6-10 (mild), 11-15 (moderate), 16-20 (severe), and 21-27 (very severe).

  change over time (baseline, 3 months, 6 months)

• Recovery Orientation

  Recovery orientation will be measured using the Recovery Assessment Scale - Short Form (RAS-SF). This 20-item scale is a shorter version of the RAS and has four factors: personal confidence and hope, willingness to ask for help, reliance on others, and no domination by symptoms. The RAS-SF shows evidence for both convergent and discriminate validity when compared to quality of life, social support, and symptomatic scales. The scale is scored by summing all items (or scale items), with 100 being the highest possible overall score. Higher scores indicate greater sense of recovery.

  change over time (baseline, 3 months, 6 months)

• Quality of Life Enjoyment and Satisfaction

  The Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a valid proxy for the longer Quality of Life Enjoyment and Satisfaction (Q-LES) form and will be used to assess quality of life. It consists of 14 items that patients rate on a 5-point scale to indicate their satisfaction with a variety of life domains, including physical health, mood, work, household activities, social relationships, etc. The Q-LES-Q-SF has been shown to have high levels of reliability and has been used in numerous studies of depression, including the National Institute of Mental Health (NIMH) funded STAR\*D study. Responses are scored on a 5-point scale, where higher scores indicate better enjoyment and satisfaction with life (possible range 14-70).

  change over time (baseline, 3 months, 6 months)

Secondary Outcomes (2)

• Cognitive Behavioral Therapy Skills

  change over time (baseline, 3 months, 6 months)

• Anxiety

  change over time (baseline, 3 months, 6 months)

Study Arms (2)

PS-cCBT

EXPERIMENTAL

peer-assisted computerized CBT

Behavioral: Peer-assisted computerized CBT

EUC

ACTIVE COMPARATOR

Enhanced usual care

Behavioral: Enhanced usual care

Interventions

Peer-assisted computerized CBT BEHAVIORAL

Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues

PS-cCBT

Enhanced usual care BEHAVIORAL

Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.

EUC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible for the study if they:
• have new episodes of depression in primary care, defined as those with a new diagnoses of depression and no prior depression diagnoses or antidepressant fills within 120 days of the index date of their depression diagnosis any of three VA study sites or associated CBOCs. Patients must enroll within 90 days of their diagnosis.
• have a current Patient Health Questionnaire (PHQ)-9 score \> 10.
• are not receiving mental health care outside of VHA.
• have broadband internet access at home or confirm willingness, ability, and a plan to go to their VA facility to complete cCBT modules.
• have familiarity with email and internet use.
• have stable access to and ability to communicate by telephone.

You may not qualify if:

• a diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) with psychotic features, or Bipolar I in the past 24 months.
• a positive screen for moderate or severe substance use (AUDIT-C \>7).
• an immediate risk of suicide, requiring hospitalization or urgent evaluation (as evidenced by suicidal plan or intent).
• participating in other research studies.
• diagnosis of depression in the past 4 months from a non-VA provider

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Battle Creek VA Medical Center, Battle Creek, MI

Battle Creek, Michigan, 49037, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Related Publications (3)

• Abraham KM, Nelson CB, Ganoczy D, Zivin K, Brandfon S, Walters H, Cohen JL, Valenstein M. Psychometric analysis of the Mental Health Recovery Measure in a sample of veterans with depression. Psychol Serv. 2016 May;13(2):193-201. doi: 10.1037/ser0000067.

  PMID: 27148954 RESULT

• Barry CN, Abraham KM, Weaver KR, Bowersox NW. Innovating team-based outpatient mental health care in the Veterans Health Administration: Staff-perceived benefits and challenges to pilot implementation of the Behavioral Health Interdisciplinary Program (BHIP). Psychol Serv. 2016 May;13(2):148-155. doi: 10.1037/ser0000072.

  PMID: 27148949 RESULT

• Pfeiffer PN, Pope B, Houck M, Benn-Burton W, Zivin K, Ganoczy D, Kim HM, Walters H, Emerson L, Nelson CB, Abraham KM, Valenstein M. Effectiveness of Peer-Supported Computer-Based CBT for Depression Among Veterans in Primary Care. Psychiatr Serv. 2020 Mar 1;71(3):256-262. doi: 10.1176/appi.ps.201900283. Epub 2020 Jan 14.

  PMID: 31931686 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Follow-up assessment rates were lower than anticipated which may have reduced overall statistical power.

Results Point of Contact

• Title: Paul Pfeiffer
• Organization: VA Center for Clinical Managment Research

paul.pfeiffer@va.gov

7348453649

Study Officials

• Paul N Pfeiffer, MD MS

  VA Ann Arbor Healthcare System, Ann Arbor, MI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: February 6, 2014
• Study Start: June 1, 2015
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: October 11, 2019
• Results First Posted: October 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)